EXCELLENT BIOPHARMA OPPORTUNITY - We require a number of Senior QA Specialist for our Cork based trailblazing biopharma client. Calling all those with Pharma or Med Devices experience.
Join a leading multinational currently expanding their team today.
Role of this position
- The Senior QA Specialist (Distribution team) will work closely with the rest of the Quality - Distribution team to ensure Good Distribution Practices (GDP) compliance as it relates to the supply of drug products to end customers via Affiliates, commercial distributors and Access Operations & Emerging Markets (AOEM) distributors. Details of duties include:
- Provide routine support to partners (e.g., affiliates; AOEM operations) in the area of GDP compliance
- Generate and maintain Quality Agreements with Affiliates/ 3rd party Distributors
- Documentation review & approval for in-market GMP/GDP activities performed by 3rd parties
- Lead and/or participate in small cross-functional working groups to deliver processes & procedures under the Corporate Support Model initiative for the EU and ROW Affiliates
- Maintains programs and processes to ensure high quality products delivered to customers and compliance with current Good Distribution Practices (GDPs).
- Collaborate cross-functionally with local and global colleagues (Supply Chain, Commercial Operations, Corporate Quality, Customer Service) to identify and implement process improvements in distribution of raw materials and finished products
- Participate in internal and external compliance audits as required, including audits of potential new distributors and on-site visits.
- Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain
- Participate in inter-site global projects in the area of distribution of APIs and Finished Products
- Support regulatory inspections as required
- Support the annual product recall challenge & participate in product recall, as required.
- 3+ years of relevant experience in the pharmaceutical industry and a BS or BA.
- Ability to work on own initiative as well as display strong teamwork skills
- Demonstrates proficiency in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP)
- Demonstrates excellent knowledge of regulations and guidelines associated with distribution supply chain of medicinal products and APIs
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
Please call Michael Hanrahan today for further information on 021-2019817 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)